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Medical Therapy With Versus Without Revascularization in Stable Patients With Moderate and Severe Ischemia: The Case for Community Equipoise.

ABSTRACT: All patients with stable ischemic heart disease (SIHD) should be managed with guideline-directed medical therapy (GDMT), which reduces progression of atherosclerosis and prevents coronary thrombosis. Revascularization is also indicated in patients with SIHD and progressive or refractory symptoms, despite medical management. Whether a strategy of routine revascularization (with percutaneous coronary intervention or coronary artery bypass graft surgery as appropriate) plus GDMT reduces rates of death or myocardial infarction, or improves quality of life compared to an initial approach of GDMT alone in patients with substantial ischemia is uncertain. Opinions run strongly on both sides, and evidence may be used to support either approach. Careful review of the data demonstrates the limitations of our current knowledge, resulting in a state of community equipoise. The ongoing ISCHEMIA trial (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches) is being performed to determine the optimal approach to managing patients with SIHD, moderate-to-severe ischemia, and symptoms that can be controlled medically. (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches [ISCHEMIA]; NCT01471522).

SUBMITTER: Stone GW

PROVIDER: S-EPMC5545795 | biostudies-literature | 2016 Jan

REPOSITORIES: biostudies-literature

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Medical Therapy With Versus Without Revascularization in Stable Patients With Moderate and Severe Ischemia: The Case for Community Equipoise.

Stone Gregg W GW Hochman Judith S JS Williams David O DO Boden William E WE Ferguson T Bruce TB Harrington Robert A RA Maron David J DJ

Journal of the American College of Cardiology 20151123 1

All patients with stable ischemic heart disease (SIHD) should be managed with guideline-directed medical therapy (GDMT), which reduces progression of atherosclerosis and prevents coronary thrombosis. Revascularization is also indicated in patients with SIHD and progressive or refractory symptoms, despite medical management. Whether a strategy of routine revascularization (with percutaneous coronary intervention or coronary artery bypass graft surgery as appropriate) plus GDMT reduces rates of de ...[more]

PMID: 26616030

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Project description:BackgroundRandomized studies have shown optimal medical therapy to be as efficacious as revascularization in stable ischemic heart disease (IHD). It is not known if these efficacy results are reflected by real-world effectiveness.ObjectiveTo evaluate the comparative effectiveness of routine medical therapy versus revascularization with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) in stable IHD.DesignObservational cohort study.PatientsStable IHD patients from 1 October 2008 to 30 September 2011, identified using a Registry of all angiography patients in Ontario, Canada.InterventionRevascularization, defined as PCI/CABG within 90 days after index angiography.Main measuresDeath, myocardial infarction (MI) or repeat PCI/CABG. Revascularization was compared to medical therapy using a) multivariable Cox-proportional hazard models with therapy strategy treated as a time-varying covariate; and b) a propensity score matched analysis. Post-angiography medication use was determined.Key resultsWe identified 39,131 stable IHD patients, of whom 15,139 were treated medically, and 23,992 were revascularized (PCI = 15,604; CABG = 8,388). Mean follow-up was 2.5 years. Revascularization was associated with fewer deaths (HR 0.76; 95 % CI 0.68-0.84; p < 0.001) ,MIs (HR 0.78; 95 % CI 0.72-0.85; p < 0.001) and repeat PCI/CABG (HR 0.59; 95 % CI 0.50-0.70; p < 0.001) than medical therapy. In the propensity-matched analysis of 12,362 well-matched pairs of revascularized and medical therapy patients, fewer deaths (8.6 % vs 12.7 %; HR 0.75; 95 % CI 0.69-0.81; p < 0.001) , MIs (11.7 % vs 14.4 %; HR 0.84; 95 % CI 0.77-0.93 p < 0.001) and repeat PCI/CABG ( 17.4 % vs 24.1 %;HR 0.67; 95 % 0.63-0.71; p < 0.001) occurred in revascularized patients, over the 4.1 years of follow-up. The revascularization patients had higher uptake of clopidogrel (70.3 % vs 27.2 %; p < 0.001), ?-blockers (78.2 % vs 76.7 %; p = 0.010), and statins (94.7 % vs 91.5 %, p < 0.001) in the 1-year post-angiogram.ConclusionsStable IHD patients treated with revascularization had improved risk-adjusted outcomes in clinical practice, potentially due to under-treatment of medical therapy patients.

Project description:BackgroundThe territory of the right coronary artery (RCA) is smaller than that of the left anterior descending artery. Previous studies have reported conflicting results when considering whether stable RCA-chronic total occlusion (CTO) should be reopened. The coexistence of diabetic and coronary artery diseases represents a severe situation. Therefore, we aimed to determine if stable RCA-CTO in diabetic patients was necessary to be reopened. To our knowledge, no studies have focused on this topic to date.MethodsWe enrolled diabetic patients with RCA-CTO who had clinical presentations of symptomatic stable angina or silent ischemia. RCA-CTO was treated with either successful revascularization (the CTO-SR group) or medical therapy (the CTO-MT group). The primary endpoint was all-cause death. Both Cox regression and propensity score matching analyses were used. Sensitivity analysis was performed based on subgroup populations and relevant baseline variables.ResultsA total of 943 patients were included: 443 (46.98%) patients in the CTO-MT group and 500 (53.02%) patients in the CTO-SR group. After a mid-term follow-up (CTO-SR: 48 months; CTO-MT: 42 months), we found that CTO-SR was superior to CTO-MT in terms of all-cause death (adjusted hazard ratio [HR] [model 1]: 0.429, 95% conference interval [CI] 0.269-0.682; adjusted HR [model 2]: 0.445, 95% CI 0.278-0.714). The superiority of CTO-SR was consistent for cardiac death, possible/definite cardiac death, repeat revascularization, target vessel revascularization (TVR) and repeat nonfatal myocardial infarction. Subgroup analysis confirmed the mortality benefit of CTO-SR by percutaneous coronary intervention (the successful CTO-PCI subgroup, 309 patients in total). While CTO-SR by coronary artery bypass grafting (the CTO-CABG subgroup, 191 patients in total) offered patients more benefit from repeat revascularization and TVR than that offered by successful CTO-PCI.ConclusionsFor stable RCA-CTO patients with diabetes, successful revascularization offered patients more clinical benefits than medical therapy. CTO-CABG might be a more recommended way to accomplish revascularization. Trial registration This study was not registered in an open access database.

Project description:The microbial community dynamics of a functionally stable, well-mixed, methanogenic reactor fed with glucose were analyzed over a 605-day period. The reactor maintained constant pH and chemical oxygen demand removal during this period. Thirty-six rrn clones from each of seven sampling events were analyzed by amplified ribosomal DNA restriction analysis (ARDRA) for the Bacteria and Archaea domains and by sequence analysis of dominant members of the community. Operational taxonomic units (OTUs), distinguished as unique ARDRA patterns, showed reproducible distribution for three sample replicates. The highest diversity was observed in the Bacteria domain. The 16S ribosomal DNA Bacteria clone library contained 75 OTUs, with the dominant OTU accounting for 13% of the total clones, but just 21 Archaea OTUs were found, and the most prominent OTU represented 50% of the clones from the respective library. Succession in methanogenic populations was observed, and two periods were distinguished: in the first, Methanobacterium formicicum was dominant, and in the second, Methanosarcina mazei and a Methanobacterium bryantii-related organism were dominant. Higher variability in Bacteria populations was detected, and the temporal OTU distribution suggested a chaotic pattern. Although dominant OTUs were constantly replaced from one sampling point to the next, phylogenetic analysis indicated that inferred physiologic changes in the community were not as dramatic as were genetic changes. Seven of eight dominant OTUs during the first period clustered with the spirochete group, although a cyclic pattern of substitution occurred among members within this order. A more flexible community structure characterized the second period, since a sequential replacement of a Eubacterium-related organism by an unrelated deep-branched organism and finally by a Propionibacterium-like species was observed. Metabolic differences among the dominant fermenters detected suggest that changes in carbon and electron flow occurred during the stable performance and indicate that an extremely dynamic community can maintain a stable ecosystem function.

Project description:BackgroundAcute limb ischemia (ALI) is an important clinical event threatening both life and the affected limbs, but the optimal treatment for ALI remains undefined. The aim of this study was to compare the safety and effectiveness of thrombectomy approaches via either catheter-based thrombectomy (CBT) or catheter-directed thrombolysis (CDT).MethodsA total of 98 patients (mean age 69.7 years, 60 male) who underwent endovascular intervention for ALI from January 2015 to July 2019 were included. Of these, 57 were treated with primary CBT via a large-bore catheter, an AngioJet catheter or Rotarex catheter, and/or underwent low-dose CDT, and 41 were treated with primary CDT. The safety and effectiveness of CBT compared to conventional CDT and other various endovascular techniques were evaluated.ResultsMore Rutherford IIb patients were treated with primary CBT (68.4%) than CDT (26.8%; P < .001). Patients who underwent primary CDT achieved a higher technical success rate than those who underwent primary CBT in a shorter procedure time (P < .001), whereas 42.1% of patients who underwent CBT did not need adjunctive CDT. The duration and dosage of adjunctive CDT in the CBT group were significantly decreased compared with those in the primary CDT group (both P < .001), and the CBT group achieved a shorter in-hospital length of stay (P < .001). Subgroup analysis revealed that patients treated with AngioJet and Rotarex catheters achieved slightly lower dosages, shorter CDT durations and shorter in-hospital stay lengths than those treated with large-bore catheters (P > .05). Clinical success was estimated to be achieved in 98.2% of patients who underwent CBT, which is similar to the 97.6% estimated in those who underwent primary CDT (P = 1.000), and this finding was similar among the CBT subgroups. Patients who underwent CBT had a higher procedure-related distal embolization rate and economic cost than those who underwent primary CDT (P < .05), but it had slightly fewer complications than those who underwent primary CDT (P = .059), especially minor complications (P = .036). The freedom from amputation at 6 and 12 months for CBT and CDT was assessed (93.0% vs 90.2% respectively, P = .625; 89.5% vs 82.9%, respectively, P = .34,). Comparable limb salvage was found for different techniques of large bore catheters, AngioJet catheters and Rotarex catheters. The Kaplan-Meier table analysis also showed similar limb salvage rates between groups.ConclusionsEndovascular treatment of ALI with the use of catheter-based therapies is an effective modality that can reduce the requirement for thrombolysis, with expected reductions in hemorrhagic complications, but at the risk of remediable distal emboli and increased economic cost. It has a similar clinical outcome to conventional CDT alone. Different CBT techniques have comparable efficacy but different adverse event profiles.

Dataset Information

Medical Therapy With Versus Without Revascularization in Stable Patients With Moderate and Severe Ischemia: The Case for Community Equipoise.

Publications

Medical Therapy With Versus Without Revascularization in Stable Patients With Moderate and Severe Ischemia: The Case for Community Equipoise.

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